Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?

After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. The purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ stent placement by evaluating the patient-reported outcomes along with laboratory tests.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Ureteral Catheterization; Flank Pain; Ureteroscopy; Complications; Urethral Catheter
• Intervention / Treatment: Procedure: urethral catheter placement

Detailed Description

Ureteral stents and foley catheters are the most commonly used disposables in urological practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons.

DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure increases during voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents.

Foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. The practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon.

The aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux and urinary tract infections.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yiloren Tanidir, Assc. Prof.; Phone Number: 905325694275; Email: yiloren@yahoo.com
• Study Contact Backup: Name: Tarik Emr Sener, M.D.; Phone Number: +5337620712; Email: dr.emresener@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34890
    • Marmara University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patients
• Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No-catheter; after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
Active Comparator: Catheter; urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones	Procedure: urethral catheter placement; urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ureteric stent symptom questionnaire (USSQ) score	evaluation of flank pain	at the 24th hour of the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
white blood cell count on complete blood count	evaluation of laboratory test results for infectious parameters	at the 24th hour of the operation
c-reactive protein (CRP) levels	evaluation of laboratory test results for infectious parameters	at the 24th hour of the operation

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Tarik Emre Sener, MD, Marmara University Hospital, Department of Urology; Study Chair: Yiloren Tanidir, Marmara University Hospital, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Pain; Neurologic Manifestations; Lower Urinary Tract Symptoms; Flank Pain
• Other Study ID Numbers: MAR.UAD.004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No